Passarini Blog
Anvisa: Public Consultation on UDI for Medical Devices
Anvisa Opens Public Consultation on UDI: Understand the New Requirements for Medical Devices The Brazilian Health Regulatory Agency (Anvisa) has announced the opening of a public consultation to gather contributions regarding the requirements for the transmission and management of the Brazilian Unique Device Identification (UDI) [...]
INMETRO Seal: Understand the Importance and Mandatory Nature of Certification
Do you know how the INMETRO Seal is Applied? The INMETRO Seal is something you've certainly seen on many products in your daily life. But do you know how it works and why it's so important? In this text, we'll explain how this seal is [...]
ANVISA: A Complete Guide to Product Regulation in Brazil
Navigating the World of ANVISA with Passarini Group You might think dealing with ANVISA is a Herculean task, an insurmountable mountain of bureaucracy that drains your company's time and resources. But the truth is that ANVISA, as a health protection agency, ensures the safety of [...]
CE Marking as Your Passport to Success
Conquer the European Market with Passarini Group: CE Marking as Your Passport to Success The European market presents a promising opportunity for Brazilian companies seeking to expand their business, especially in the innovative medical products sector. While you may think that investing in CE certification [...]
The Importance of Quality Systems for the Medical Device Industry
The Importance of Quality Systems for the Medical Device Industry In the competitive global medical device market, quality and safety are paramount. Companies in the sector face the challenge of meeting stringent regulations and ensuring compliance with international standards. In this context, the implementation of [...]
Understand the impact of the FDA fee adjustment on your business
FDA Increases Fees by up to 21% for Fiscal Year 2025: What You Need to Know. The FDA (Food and Drug Administration) announced on August 1, 2024, the new fees for Fiscal Year 2025 (FY25). Companies that manufacture or distribute medical devices for the US [...]
